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Original-Research: CEL-SCI Corporation - from First Berlin Equity Research GmbH
Classification of First Berlin Equity Research GmbH to CEL-SCI Corporation
First Berlin Equity Research has published a research update on CEL-SCI Corporation (ISIN: US1508376076). Analyst Christian Orquera reiterated his BUY rating and maintained his USD 6.20 price target. Abstract: CEL-SCI's 9M 23/24 financial results (as of 30 June 2024) were roughly as expected. The company reported no revenue and reduced its OPEX compared to the previous year. EBIT came in at USD-20.2m (9M 22/23: USD-24.0m) and the cash position dropped to just USD385k (FY 22/23: USD22.7m). However, in July 2024, CEL-SCI carried out a capital increase of USD10.85m. The company's cash position should now be sufficient to finance operations into Q1 2025. Given CEL-SCI's plan to start a confirmatory trial of the lead drug candidate Multikine in Q4 2024/Q1 2025, we expect the company to conduct another capital increase. We estimate that the confirmatory study will cost ~USD30m, part of which may be paid by CEL-SCI's marketing partners Teva Pharmaceuticals (based in Israel) and Orient Europharma (based in Taiwan). The green light given by the FDA in May 2024 for the confirmatory study provided a clear path to approval and therefore is a good basis for the additional financing. The company also published positive results of a recent bias analysis of its completed Multikine phase 3 study. A bias analysis is a standard procedure to ensure that the results of a study are reliable. The outcome was that the study showed no bias in favour of the drug. This analysis reinforces our positive view on Multikine's prospects as a potential new first line treatment of locally advanced primary head and neck squamous cell carcinoma (HNSCC). We reiterate our Buy recommendation and price target of USD6.20. First Berlin Equity Research hat ein Research Update zu CEL-SCI Corporation (ISIN: US1508376076) veröffentlicht. Analyst Christian Orquera bestätigt seine BUY-Empfehlung und bestätigt sein Kursziel von USD 6,20. Zusammenfassung: Die Finanzergebnisse von CEL-SCI für 9M 23/24 (zum 30. Juni 2024) fielen in etwa wie erwartet aus. Das Unternehmen verzeichnete keinen Umsatz und verringerte seine Betriebsaufwendungen im Vergleich zum Vorjahr. Das EBIT belief sich auf USD-20,2 Mio. (9M 22/23: USD-24,0 Mio.), und der Kassenbestand sank auf nur noch USD385 tsd. (GJ 22/23: USD22,7 Mio.). Im Juli 2024 führte CEL-SCI jedoch eine Kapitalerhöhung von USD10,85 Mio. durch. Der Barmittelbestand des Unternehmens dürfte nun ausreichen, um den Betrieb bis zum ersten Quartal 2025 zu finanzieren. Angesichts des Plans von CEL-SCI, die Bestätigungsstudie im 4. Quartal 2024/1. Quartal 2025 zu beginnen, erwarten wir, dass das Unternehmen eine weitere Kapitalerhöhung durchführen wird. Wir schätzen, dass die Bestätigungsstudie ~USD30 Mio. kosten wird, wovon ein Teil von CEL-SCIs Marketingpartnern Teva Pharmaceuticals (mit Sitz in Israel) und Orient Europharma (mit Sitz in Taiwan) bezahlt werden könnte. Die im Mai 2024 erteilte FDA-Genehmigung für die Bestätigungsstudie des führenden Medikamentenkandidaten Multikine bietet einen klaren Weg zur Zulassung und ist daher eine gute Grundlage für die zusätzliche Finanzierung. Das Unternehmen veröffentlichte außerdem positive Ergebnisse einer kürzlich durchgeführten Bias-Analyse seiner abgeschlossenen Multikine-Phase-3-Studie. Eine Bias-Analyse ist ein Standardverfahren, mit dem sichergestellt werden soll, dass die Ergebnisse einer Studie zuverlässig sind. Das Ergebnis war, dass die Studie keine Verzerrung zugunsten des Medikaments ergab. Diese Analyse bestärkt uns in unserer positiven Einschätzung der Aussichten von Multikine als potenzielle neue Erstlinienbehandlung des lokal fortgeschrittenen primären Plattenepithelkarzinoms im Kopf- und Halsbereich (HNSCC). Wir bekräftigen unsere Kaufempfehlung und unser Kursziel von USD6,20. Bezüglich der Pflichtangaben gem. §85 Abs. 1 S. 1 WpHG und des Haftungsausschlusses siehe die vollständige Analyse. You can download the research here: http://www.more-ir.de/d/30715.pdf Contact for questions: First Berlin Equity Research GmbH Herr Gaurav Tiwari Tel.: +49 (0)30 809 39 686 web: www.firstberlin.com E-Mail: g.tiwari@firstberlin.com
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